FDA approves Teva’s tbo-filgrastim for severe neutropenia

On August 29, 2012, the U.S. FDA approved Sicor Biotech’s BLA for tbo-filgrastim (XMO2 filgrastim), to reduce the time certain patient receiving chemotherapy experience severe neutropenia, a decrease in white blood cells that leaves the patient susceptible to certain types of potentially life-threatening bacterial infections. Sicor is a member of the Teva Corporation.

Tbo-filgrastim’s approval was based, in part on an efficacy study of 348 adult patients with advanced breast cancer receiving doxorubicin and docetaxel.  During the first 21 day cycle, patients receiving tbo-filgrastim recovered from severe neutropenia in 1.1 days compared to 3.8 days in those receiving a placebo.

According to a settlement agreement with Amgen, Teva is prohibited from selling its filgrastim product until November 10, 2013, or sooner if certain unexpected events occur.  Tbo-filgrastim is a solution for subcutaneous injection and will be supplied as a single use, preservative-free, prefilled syringe in doses of 300mcg/0.5mL and 480 mcg/0.8mL.

Teva’s and the FDA’s press releases announcing the approval may be found here and here.